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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002717-35 | EudraCT Number | ||
| C3431008 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
| Medivation, Inc. | INDUSTRY |
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The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.
This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2-Normal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide & exemestane | Experimental | Enzalutamide 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) once daily after food. |
|
| Placebo & exemestane | Active Comparator | Placebo and exemestane 25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet without placebo after unblinding) once daily after food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS) | PFS was defined as the time in months from randomization to the first documentation of progression of disease (PD) or death on study due to any cause, whichever occurred first. PD according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) was defined as greater than or equal to (>=) 20 percent (%) increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. | From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) |
| Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Interactive Web Recognition System (IWRS) | PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as >= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. | From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate-24 (CBR-24) | CBR-24: Percentage of participants with a best response of complete response (CR), partial response (PR), or stable disease (SD) sustained for atleast 24 weeks, as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (less than [<] 10 millimeter [mm] short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during study as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life | The EORTC QLQ-C30 questionnaire was a standardized instrument developed to assess the quality of life of people with cancer. Participants self-rated their self-care, activity level, pain/discomfort, and mental health during the past week by choosing 1 of 4 possible responses that recorded the level of intensity (not at all, a little, quite a bit, and very much) within each dimension, where higher score=more level of intensity. The questionnaire also asked the participants to rate their overall health or quality of life within the past week on a scale of 1 to 7, where 1 is "very poor" and 7 is "excellent". Higher global health or quality of life scores indicated better overall health or quality of life. In this outcome measure, global health/quality of life scores are presented. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATTN-Research Pharmacist | Aurora | Colorado | 80045 | United States | ||
| University of Colorado Cancer Center - Anschutz Cancer Pavilion |
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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This was a phase 2, randomized, double blind, placebo-controlled study.
A total of 247 participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg | Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Treatment Period |
|
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| exemestane | Drug | 25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet after unblinding) by mouth once daily after food. |
|
|
| Placebo (for enzalutamide) | Drug | Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food. |
|
| exemestane | Drug | 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) by mouth once daily after food. |
|
|
| From randomization up to 3 years |
| Best Objective Response Rate | Best objective response rate: Percentage of participants with measurable disease and with a best response of CR or PR according to RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: Atleast 30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. Response evaluation was based on investigators' judgment. | From randomization until CR or PR, whichever occurred first (up to 3 years) |
| Duration of Objective Response | Duration of objective response: Time from first documentation of CR or PR, to the first documentation of PD or death due to any cause, whichever occurred first as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants with no PD or death (after initial CR or PR) at the analysis date were censored at last tumor assessment date prior to date of new antitumor treatment or data cutoff. | From first documentation of CR or PR until PD, or last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) |
| Time to Response | Time to response: Time from randomization to first documentation of CR or PR. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who were not known to have had a CR or PR were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. | From randomization until first documentation of CR or PR, or last tumor assessment without PD or death prior to new antitumor treatment initiation, whichever occurred first (up to 3 years) |
| Time to Progression | Time to progression was defined as the time from the date of randomization to PD defined by the investigator using RECIST 1.1. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who did not experience disease progression, time to progression was right censored at the date of the last tumor assessment prior to data cutoff or date of new antitumor treatment, whichever occurred first. | From randomization until PD or last tumor assessment without PD before new antitumor treatment initiation, whichever occurred first (up to 3 years) |
| Progression Free Survival (PFS) at 6 Months | PFS at 6 months was defined as the percentage of participants with no event of disease progression at Month 6 landmark, estimated by Kaplan-Meier methods. PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. The analysis of PFS was based on investigator assessment of disease progression. | Month 6 |
| Concentration Versus Time Summary of Enzalutamide | Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero. | Predose on Day 29, 57 and 113 |
| Concentration Versus Time Summary of Exemestane | Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero. | Predose, 1 and 6 hour postdose on Day 29, 57, 113 and 169 |
| Concentration Versus Time Summary of N-desmethyl Enzalutamide | N-desmethyl enzalutamide was the active metabolite of enzalutamide. Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero. | Predose on Day 29, 57 and 113 |
| Baseline; Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133 |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133 | EORTC QLQ-BR23 was disease-specific module for breast cancer developed as supplement for EORTC QLQ-C30 that assessed quality of life of participants with breast cancer.Participants self-rated on frequent symptoms or problems reported by participants with breast cancer,e.g., pain/discomfort, body satisfaction, and self-esteem during past week by choosing 1 of 4 possible responses that recorded level of intensity (not at all, a little, quite a bit, and very much) within each dimension.Raw scores were then transformed to 0-100 scale for analysis and interpretation, where higher scores=more level of intensity, as per EORTC guidelines.Participants also self-rated on sexual health/interest during last 4 weeks using same scale. In this outcome measure body image functioning, sexual functioning, systemic therapy side effects, upset by hair loss parameters were assessed by EORTC QLQ-BR23 questionnaire,total score for each parameter ranged from 0-100,where higher scores=more level of intensity. | Baseline; Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133 |
| Number of Participants With Positive Androgen Receptor (AR) Expression by Immunohistochemistry (IHC) | Day 1, 29, 57, 113 and 169 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs. | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (approximately up to 10.13 years) |
| Number of Participants With Treatment-Emergent Adverse Events of Grade 3 or Higher Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only the participants with treatment-emergent AEs of grade 3 (severe) or higher grade were reported in this outcome measure. | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (approximately up to 10.13 years) |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Criteria for clinically significant vital sign abnormalities: Systolic blood pressure (SBP): absolute SBP <90 millimeters of mercury (mmHg) and decrease from baseline (DFB) >30 mmHg, absolute SBP>180 mmHg and increase from baseline (IFB) >40 mmHg, final visit or 2 consecutive visits SBP >=20 mmHg change from baseline (CFB), most extreme post-baseline SBP >=140 mmHg, most extreme post-baseline SBP >=180 mmHg, most extreme SBP >=140 mmHg and >=20 mmHg CFB, most extreme SBP >=180 mmHg and >=20 mmHg CFB; diastolic blood pressure (DBP): absolute DBP > 105 mmHg and IFB >30 mmHg, absolute DBP <50 mmHg and DFB >20 mmHg, final visit or 2 consecutive visits DBP >=15 mmHg CFB, most extreme post-baseline DBP >=90 mmHg, most extreme post-baseline DBP >=105 mmHg, most extreme DBP >=90 mmHg and >=15 mmHg CFB, most extreme DBP >=105 mmHg and >=15 mmHg CFB; heart rate <50 beats per minute (BPM) and DFB >20 BPM or heart rate >120 BPM and IFB >30 BPM. | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (approximately up to 10.13 years) |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Laboratory tests included hematology (hematocrit, hemoglobin, platelet count, red blood cell count, total neutrophils [absolute] and white blood cell count with differential) and serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase [ALT], aspartate transaminase [AST], blood urea nitrogen and creatinine, calcium, sodium, potassium, chloride, glucose (non-fasting), lactate dehydrogenase, magnesium, phosphorus/phosphate, total bilirubin, total bicarbonate, total protein and uric acid). Clinically significant abnormality evaluation was based on clinical investigator's judgment. | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years) |
| Progression Free Survival (PFS): By Electronic Data Capture (EDC) | PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1 was defined >=20 % increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. Cht 1: Enz + Exe = Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg; Cht 2: Enz + Exe= Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) |
| Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Electronic Data Capture (EDC) | PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as >= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. | From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Colorado Hospital, Anschutz Outpatient Pavilion | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80907 | United States |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | 80124 | United States |
| Florida Cancer Specialists | Altamonte Springs | Florida | 32701 | United States |
| Florida Cancer Specialists | Bonita Springs | Florida | 34135 | United States |
| Florida Cancer Specialists | Bradenton | Florida | 34209 | United States |
| Florida Cancer Specialists | Brandon | Florida | 33511 | United States |
| Florida Cancer Specialists | Cape Coral | Florida | 33909 | United States |
| Florida Cancer Specialists | Clearwater | Florida | 33761 | United States |
| Florida Cancer Specialists | Englewood | Florida | 34223 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33905 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33908 | United States |
| Florida Cancer Specialists | Gainesville | Florida | 32605 | United States |
| Florida Cancer Specialists | Hudson | Florida | 34667 | United States |
| Florida Cancer Specialists | Largo | Florida | 33770 | United States |
| Florida Cancer Specialists | Naples | Florida | 34102 | United States |
| Florida Cancer Specialists | New Port Richey | Florida | 34655 | United States |
| Florida Cancer Specialists | Orange City | Florida | 32763 | United States |
| Florida Cancer Specialists | Orlando | Florida | 32806 | United States |
| Florida Cancer Specialists | Port Charlotte | Florida | 33980 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34236 | United States |
| Florida Cancer Specialists | Spring Hill | Florida | 34608 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists | Tampa | Florida | 33607 | United States |
| Florida Cancer Specialists | Tavares | Florida | 32778 | United States |
| Florida Cancer Specialists | Venice | Florida | 34285 | United States |
| Florida Cancer Specialists | Venice | Florida | 34292 | United States |
| Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| The University of Chicago Medical Center, | Chicago | Illinois | 60637 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Chicago Comprehensive Cancer Center at Silver Cross Hospital | New Lenox | Illinois | 60451 | United States |
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | United States |
| Indiana University Health Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Investigational Drug Services | Indianapolis | Indiana | 46202 | United States |
| Sidney and Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States |
| Springmill Medical Clinic | Indianapolis | Indiana | 46290 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Minnesota Oncology Hematology, P.A | Minneapolis | Minnesota | 55404 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Allina Health System DBA Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | United States |
| Dr.Michaela Tsai | Minneapolis | Minnesota | 55407 | United States |
| The West Clinic, P.C. | Corinth | Mississippi | 38834 | United States |
| The West Clinic, P.C. d/b/a West Cancer Center | Southaven | Mississippi | 38671 | United States |
| Siteman Cancer Center | City of Saint Peters | Missouri | 63376 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington University Infusion Center Pharmacy | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Siteman Cancer Center- West County | St Louis | Missouri | 63141 | United States |
| Hematology Oncology Associates of Northern NJ | Morristown | New Jersey | 07962 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45202 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45211 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45230 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45236 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45242 | United States |
| Oncology Hematology Care, Inc. | Fairfield | Ohio | 45014 | United States |
| Greenville Health System | Greenville | South Carolina | 29605 | United States |
| Greenville Health System | Seneca | South Carolina | 29672 | United States |
| Greenville Health System | Spartanburg | South Carolina | 29307 | United States |
| Tennessee Oncology, PLLC | Franklin | Tennessee | 37067 | United States |
| Tennessee Oncology, PLLC | Gallatin | Tennessee | 37066 | United States |
| The West Clinic, P.C. d/b/a West Cancer Center | Germantown | Tennessee | 38138 | United States |
| Tennessee Oncology, PLLC | Hermitage | Tennessee | 37076 | United States |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37090 | United States |
| The West Clinic, P.C. d/b/a West Cancer Center | Memphis | Tennessee | 38104 | United States |
| Tennessee Oncology, PLLC | Murfreesboro | Tennessee | 37129 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Breast Center at One Hundred Oaks | Nashville | Tennessee | 37204 | United States |
| Vanderbilt Health Pharmacy One Hundred Oaks | Nashville | Tennessee | 37204 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37207 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37211 | United States |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | United States |
| Tennessee Oncology, PLLC | Shelbyville | Tennessee | 37160 | United States |
| Tennessee Oncology, PLLC | Smyrna | Tennessee | 37167 | United States |
| Texas Oncology - Memorial City | Houston | Texas | 77024 | United States |
| Texas Oncology-Longview Cancer Center | Longview | Texas | 75601 | United States |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | United States |
| Virginia Cancer Institute | Mechanicsville | Virginia | 23116 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23235 | United States |
| UZA | Edegem | Antwerpen | 2650 | Belgium |
| GZA | Wilrijk | Antwerpen | 2610 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Sunnybrook Research Institute | Toronto | Ontario | M4N 3M5 | Canada |
| McGill University Health Center- Cedars Cancer Center | Montreal | Quebec | H4A 3J1 | Canada |
| McGill University Health Centre - Cedars Cancer Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Pharmacy Department | Dublin | 4 | Ireland |
| Radiology Department | Dublin | 4 | Ireland |
| St Vincent's University Hospital | Dublin | 4 | Ireland |
| Institute for Cancer Research | Dublin | 7 | Ireland |
| Mater Private Hospital | Dublin | 7 | Ireland |
| Pharmacy Department | Dublin | 7 | Ireland |
| Radiology Department | Dublin | 7 | Ireland |
| Cancer Clinical Trials Unit | Dublin | D9 | Ireland |
| Pharmacy Department | Dublin | D9 | Ireland |
| Radiology Department | Dublin | D9 | Ireland |
| Institute for Cancer Research | Dublin | Ireland |
| Mater Private Hospital | Dublin | Ireland |
| Pharmacy Department | Dublin | Ireland |
| Radiology Department | Dublin | Ireland |
| IRCCS Ospedale San Raffaele | Milan | MI | 20132 | Italy |
| Divisione di Senologia Medica; Istituto Europeo di Oncologia | Milan | MI | 20141 | Italy |
| A.O.di Perugia S. Maria Della Misericoridia | Perugia | PG | 06132 | Italy |
| Azienda Ospedaliera S.Orsola Malpighi | Bologna | 40138 | Italy |
| U.O. Farmaceutica, Nuovo Ospedale di Prato | Prato | 59100 | Italy |
| U.O. Oncologia Medica, Nuovo Ospedale di Prato | Prato | 59100 | Italy |
| Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena | Roma | 00144 | Italy |
| Hospital Universitario HM Monteprincipe | Boadilla del Monte | Madrid | 28660 | Spain |
| Grupo Hospitalario Quiron - Hospital Universitari Quiron Dexeus | Barcelona | 08028 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 Octubre | Madrid | 28041 | Spain |
| Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital de Madrid Norte Sanchinarro | Madrid | 28050 | Spain |
| Brighton and Sussex University Hospital NHS Trust | Brighton | England | BN2 5BE | United Kingdom |
| Pharmacy Department | Brighton | England | BN2 5BE | United Kingdom |
| Radiation Safety Service, Medical Physics Department | Brighton | England | BN2 5BE | United Kingdom |
| Histopathology Department | Nottingham | England | NG5 1PB | United Kingdom |
| Nottingham University Hospital | Nottingham | England | NG5 1PB | United Kingdom |
| Pharmacy Department | Nottingham | England | NG5 1PB | United Kingdom |
| Radiology Department | Nottingham | England | NG5 1PB | United Kingdom |
| Radiology Department | Nottingham | England | NG7 2UH | United Kingdom |
| Department of Radiology | Truro | England | TR1 3LJ | United Kingdom |
| Pharmacy Department | Truro | England | TR1 3LJ | United Kingdom |
| Royal Cornwall Hospitals NHS trust | Truro | England | TR1 3LJ | United Kingdom |
| Clinical Investigation & Research Unit | Brighton | Sussex | BN2 5BE | United Kingdom |
| FG001 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| FG002 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| FG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
| Open Label Treatment Period |
|
|
Intent-to-treat (ITT) population included all the participants randomly assigned to double-blind study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg | Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| BG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| BG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| BG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS) | PFS was defined as the time in months from randomization to the first documentation of progression of disease (PD) or death on study due to any cause, whichever occurred first. PD according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) was defined as greater than or equal to (>=) 20 percent (%) increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. | ITT population included all the participants randomly assigned to double-blind study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) |
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| Primary | Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Interactive Web Recognition System (IWRS) | PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as >= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. | Dx+ population: Subset of ITT population, defined prior to the first unblinded analysis as meeting the threshold for diagnostic score based on ribonucleic acid (RNA) sequencing data from tumor tissue. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) |
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| Secondary | Clinical Benefit Rate-24 (CBR-24) | CBR-24: Percentage of participants with a best response of complete response (CR), partial response (PR), or stable disease (SD) sustained for atleast 24 weeks, as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (less than [<] 10 millimeter [mm] short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during study as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. | ITT population included all the participants randomly assigned to double-blind study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to 3 years |
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| Secondary | Best Objective Response Rate | Best objective response rate: Percentage of participants with measurable disease and with a best response of CR or PR according to RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: Atleast 30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. Response evaluation was based on investigators' judgment. | ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants with measurable response. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until CR or PR, whichever occurred first (up to 3 years) |
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| Secondary | Duration of Objective Response | Duration of objective response: Time from first documentation of CR or PR, to the first documentation of PD or death due to any cause, whichever occurred first as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants with no PD or death (after initial CR or PR) at the analysis date were censored at last tumor assessment date prior to date of new antitumor treatment or data cutoff. | ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From first documentation of CR or PR until PD, or last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) |
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| Secondary | Time to Response | Time to response: Time from randomization to first documentation of CR or PR. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who were not known to have had a CR or PR were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. | ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From randomization until first documentation of CR or PR, or last tumor assessment without PD or death prior to new antitumor treatment initiation, whichever occurred first (up to 3 years) |
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| Secondary | Time to Progression | Time to progression was defined as the time from the date of randomization to PD defined by the investigator using RECIST 1.1. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who did not experience disease progression, time to progression was right censored at the date of the last tumor assessment prior to data cutoff or date of new antitumor treatment, whichever occurred first. | ITT population included all the participants randomly assigned to double-blind study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization until PD or last tumor assessment without PD before new antitumor treatment initiation, whichever occurred first (up to 3 years) |
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| Secondary | Progression Free Survival (PFS) at 6 Months | PFS at 6 months was defined as the percentage of participants with no event of disease progression at Month 6 landmark, estimated by Kaplan-Meier methods. PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. The analysis of PFS was based on investigator assessment of disease progression. | ITT population included all the participants randomly assigned to double-blind study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
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| Secondary | Concentration Versus Time Summary of Enzalutamide | Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero. | Pharmacokinetic (PK) population for enzalutamide included all participants in safety population who received any amount of enzalutamide and had at least 1 reportable concentration value for enzalutamide or its active metabolite (N-desmethyl enzalutamide). | Posted | Mean | Standard Deviation | microgram per milliliter | Predose on Day 29, 57 and 113 |
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| Secondary | Concentration Versus Time Summary of Exemestane | Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero. | PK population for exemestane was defined as all participants in the safety population who received any amount of exemestane and had at least 1 reportable plasma concentration value for exemestane. | Posted | Mean | Standard Deviation | Picogram per milliliter | Predose, 1 and 6 hour postdose on Day 29, 57, 113 and 169 |
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| Secondary | Concentration Versus Time Summary of N-desmethyl Enzalutamide | N-desmethyl enzalutamide was the active metabolite of enzalutamide. Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero. | PK population for N-desmethyl enzalutamide included all the participants in safety population who received any amount of enzalutamide and had at least 1 reportable concentration value for N-desmethyl enzalutamide. | Posted | Mean | Standard Deviation | microgram per milliliter | Predose on Day 29, 57 and 113 |
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| Other Pre-specified | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133: Global Health/Quality of Life | The EORTC QLQ-C30 questionnaire was a standardized instrument developed to assess the quality of life of people with cancer. Participants self-rated their self-care, activity level, pain/discomfort, and mental health during the past week by choosing 1 of 4 possible responses that recorded the level of intensity (not at all, a little, quite a bit, and very much) within each dimension, where higher score=more level of intensity. The questionnaire also asked the participants to rate their overall health or quality of life within the past week on a scale of 1 to 7, where 1 is "very poor" and 7 is "excellent". Higher global health or quality of life scores indicated better overall health or quality of life. In this outcome measure, global health/quality of life scores are presented. | ITT population included all the participants randomly assigned to double-blind study treatment. Here, "Overall Number of Participants Analyzed" contributed data to table but may not have evaluable data for every row and "Number Analyzed" signifies participants evaluable for the specified rows and value as "0" indicated no participants filled the questionnaire for the specified reporting group at specified timepoint. | Posted | Mean | Standard Deviation | Units on a scale | Baseline; Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133 |
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| Other Pre-specified | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) at Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133 | EORTC QLQ-BR23 was disease-specific module for breast cancer developed as supplement for EORTC QLQ-C30 that assessed quality of life of participants with breast cancer.Participants self-rated on frequent symptoms or problems reported by participants with breast cancer,e.g., pain/discomfort, body satisfaction, and self-esteem during past week by choosing 1 of 4 possible responses that recorded level of intensity (not at all, a little, quite a bit, and very much) within each dimension.Raw scores were then transformed to 0-100 scale for analysis and interpretation, where higher scores=more level of intensity, as per EORTC guidelines.Participants also self-rated on sexual health/interest during last 4 weeks using same scale. In this outcome measure body image functioning, sexual functioning, systemic therapy side effects, upset by hair loss parameters were assessed by EORTC QLQ-BR23 questionnaire,total score for each parameter ranged from 0-100,where higher scores=more level of intensity. | ITT population included all the participants randomly assigned to double-blind study treatment. Here, "Overall Number of Participants Analyzed" contributed data to table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for the specified rows and value as "0" indicated no participants filled the questionnaire for the specified reporting group at specified timepoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline; Weeks 5, 9, 17, 25, 33, 41, 49, 61, 73, 85, 97, 109, 121 and 133 |
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| Other Pre-specified | Number of Participants With Positive Androgen Receptor (AR) Expression by Immunohistochemistry (IHC) | Protocol of this study was amended and data for this outcome measure was not analyzed as per planned analysis. | Posted | Day 1, 29, 57, 113 and 169 |
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs. | Safety population included all the participants who received study drug either in double blind or in open label treatment period. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (approximately up to 10.13 years) |
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events of Grade 3 or Higher Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only the participants with treatment-emergent AEs of grade 3 (severe) or higher grade were reported in this outcome measure. | Safety population included all the participants who received study drug either in double blind or in open label treatment period. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (approximately up to 10.13 years) |
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| Other Pre-specified | Number of Participants With Clinically Significant Vital Sign Abnormalities | Criteria for clinically significant vital sign abnormalities: Systolic blood pressure (SBP): absolute SBP <90 millimeters of mercury (mmHg) and decrease from baseline (DFB) >30 mmHg, absolute SBP>180 mmHg and increase from baseline (IFB) >40 mmHg, final visit or 2 consecutive visits SBP >=20 mmHg change from baseline (CFB), most extreme post-baseline SBP >=140 mmHg, most extreme post-baseline SBP >=180 mmHg, most extreme SBP >=140 mmHg and >=20 mmHg CFB, most extreme SBP >=180 mmHg and >=20 mmHg CFB; diastolic blood pressure (DBP): absolute DBP > 105 mmHg and IFB >30 mmHg, absolute DBP <50 mmHg and DFB >20 mmHg, final visit or 2 consecutive visits DBP >=15 mmHg CFB, most extreme post-baseline DBP >=90 mmHg, most extreme post-baseline DBP >=105 mmHg, most extreme DBP >=90 mmHg and >=15 mmHg CFB, most extreme DBP >=105 mmHg and >=15 mmHg CFB; heart rate <50 beats per minute (BPM) and DFB >20 BPM or heart rate >120 BPM and IFB >30 BPM. | Safety population included all the participants who received study drug either in double blind or in open label treatment period. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (approximately up to 10.13 years) |
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| Other Pre-specified | Number of Participants With Clinically Significant Laboratory Abnormalities | Laboratory tests included hematology (hematocrit, hemoglobin, platelet count, red blood cell count, total neutrophils [absolute] and white blood cell count with differential) and serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase [ALT], aspartate transaminase [AST], blood urea nitrogen and creatinine, calcium, sodium, potassium, chloride, glucose (non-fasting), lactate dehydrogenase, magnesium, phosphorus/phosphate, total bilirubin, total bicarbonate, total protein and uric acid). Clinically significant abnormality evaluation was based on clinical investigator's judgment. | Safety population included all the participants who received study drug either in double blind or in open label treatment period. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years) |
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| Other Pre-specified | Progression Free Survival (PFS): By Electronic Data Capture (EDC) | PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1 was defined >=20 % increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. Cht 1: Enz + Exe = Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg; Cht 2: Enz + Exe= Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Analysis was performed on all randomized participants. Randomization to cohort was based on participant's exposure to advance setting hormonal therapy. Initial randomization was done by IWRS. Later, upon detailed data entry in EDC, it was determined 1 participant was incorrectly assigned to Cht1:Enz+Exe by IWRS,hence counted in Cht2:Enz+Exe by EDC. | Posted | Median | 95% Confidence Interval | Months | From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) |
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| Other Pre-specified | Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Electronic Data Capture (EDC) | PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as >= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. | Dx+ population: Subset of ITT population, defined prior to the first unblinded analysis as meeting the threshold for diagnostic score based on ribonucleic acid (RNA) sequencing data from tumor tissue. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) |
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Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 10.13 years)
Same event may appear as both an adverse event (AE) and a serious AE, but they are distinct events. Event may be categorized as serious in one participant and as non-serious in another, or one may have experienced both serious and non-serious event during study. AEs and all-cause mortality were collected and evaluated for safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg | Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. | 2 | 62 | 14 | 62 | 59 | 62 |
| EG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. | 8 | 63 | 13 | 63 | 57 | 63 |
| EG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. | 3 | 60 | 10 | 60 | 57 | 60 |
| EG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. | 2 | 60 | 8 | 60 | 52 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
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| FAECES DISCOLOURED | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| OESOPHAGEAL STENOSIS | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| CHILLS | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| DISEASE PROGRESSION | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| FACIAL PAIN | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| FATIGUE | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| PAIN | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
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| HEPATIC HAEMORRHAGE | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
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| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| BREAST CELLULITIS | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| PYELONEPHRITIS | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| WOUND INFECTION | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
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| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
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| LACERATION | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| OPTIC NERVE INJURY | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| RADIATION PNEUMONITIS | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| TRAUMATIC HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| MASTICATION DISORDER | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| ADENOCARCINOMA PANCREAS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| BREAST CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| CONTRALATERAL BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| LYMPHANGIOSIS CARCINOMATOSA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| MALIGNANT ASCITES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| MALIGNANT PLEURAL EFFUSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| METASTATIC PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| PLASMA CELL MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| BRACHIAL PLEXOPATHY | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| GRAND MAL CONVULSION | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| INTRACRANIAL HAEMATOMA | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| SPEECH DISORDER | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| STATUS EPILEPTICUS | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| AMNESIA | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| DEPRESSED MOOD | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540278 | enzalutamide |
| C056516 | exemestane |
Not provided
Not provided
Not provided
| Other |
|
| Disease progression |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Stratified log-rank |
| 0.9212 |
| Hazard Ratio (HR) |
| 1.022 |
| 2-Sided |
| 95 |
| 0.659 |
| 1.586 |
| Other |
| OG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
|
| OG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
| OG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
| OG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| OG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
| Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg |
Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
| Cohort 1: Placebo + Exemestane 25 mg |
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
| OG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
|
|
Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
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|
| OG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
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|
| OG001 | Cohort 1: Placebo + Exemestane 25 mg | Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG002 | Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
| OG003 | Cohort 2: Placebo + Exemestane 25 mg | Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first. |
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